Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction
NCT ID: NCT04429165
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
68 participants
OBSERVATIONAL
2020-04-23
2022-07-14
Brief Summary
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Detailed Description
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The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest 2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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ACL reconstruction
ACL reconstruction using an autologous hamstring tendon
collection of Patient Reported Outcome (PRO) data
collection of Patient Reported Outcome (PRO) data by questionnaires
collection of anthropometric and clinical functional data
collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity
gait analysis
gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded
control group
knee-healthy, age-matched subjects as a control group
collection of Patient Reported Outcome (PRO) data
collection of Patient Reported Outcome (PRO) data by questionnaires
collection of anthropometric and clinical functional data
collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity
gait analysis
gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded
Interventions
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collection of Patient Reported Outcome (PRO) data
collection of Patient Reported Outcome (PRO) data by questionnaires
collection of anthropometric and clinical functional data
collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity
gait analysis
gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded
Eligibility Criteria
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Inclusion Criteria
* Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee
Exclusion Criteria
* neuromuscular diseases that affect lower limb movement
* Inability to give informed consent
* Patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee
18 Years
60 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Sebastian Mueller, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Traumatology, University Hospital Basel
Locations
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Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, , Switzerland
Countries
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References
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Buhl L, Muller S, Nuesch C, Boyer KA, Casto E, Mundermann A, Egloff C. Ambulatory knee biomechanics and muscle activity 2 years after ACL surgery: InternalBraceTM-augmented ACL repair versus ACL reconstruction versus healthy controls. BMC Musculoskelet Disord. 2023 Oct 4;24(1):785. doi: 10.1186/s12891-023-06916-7.
Buhl L, Muller S, Nuesch C, Pagenstert G, Mundermann A, Egloff C. Functional leg performance 2 years after ACL surgery: a comparison between InternalBrace-augmented repair versus reconstruction versus healthy controls. J Orthop Traumatol. 2023 Sep 21;24(1):52. doi: 10.1186/s10195-023-00723-5.
Muller S, Buhl L, Nuesch C, Pagenstert G, Mundermann A, Egloff C. Favorable Patient-Reported, Clinical, and Functional Outcomes 2 Years After ACL Repair and InternalBrace Augmentation Compared With ACL Reconstruction and Healthy Controls. Am J Sports Med. 2023 Oct;51(12):3131-3141. doi: 10.1177/03635465231194784. Epub 2023 Sep 7.
Muller S, Buhl L, Nuesch C, Pagenstert G, Mundermann A, Egloff C. RetroBRACE: clinical, socioeconomic and functional-biomechanical outcomes 2 years after ACL repair and InternalBrace augmentation in comparison to ACL reconstruction and healthy controls-experimental protocol of a non-randomised single-centre comparative study. BMJ Open. 2022 Feb 1;12(2):e054709. doi: 10.1136/bmjopen-2021-054709.
Other Identifiers
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2020-00551; ch20Rikli
Identifier Type: -
Identifier Source: org_study_id
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